MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio completed other unrelated repairs on the device.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio downloaded the device's electronic records from the event for review and was able to verify that the device failed to deliver a shock when the user pressed the shock button.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was used during a patient event and would not shock when they were attempting to perform a synchronized cardioversion procedure the device also displayed the service indicator.The user powered the device off and back on and was then able to deliver a shock to the patient.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has made multiple attempts to contact the customer in order to obtain additional information on the patient; however, no response has been received.
Event or Problem Description
The customer contacted physio-control to report that their device was used during a patient event and would not shock when they were attempting to perform a synchronized cardioversion procedure the device also displayed the service indicator.The user powered the device off and back on and was then able to deliver a shock to the patient.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has made multiple attempts to contact the customer in order to obtain additional information on the patient; however, no response has been received.
Additional Manufacturer Narrative
Gtin/device identifier (di) number ¿ (b)(4).

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7478675
• Report Number: 0003015876-2018-00699
• Device Sequence Number: 194578
• Product Code: MKJ
• UDI-Device Identifier: 00883873912836
• UDI-Public: 00883873912836
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1